| Primary Device ID | 07290018378045 |
| NIH Device Record Key | ed9664c6-6f17-4f81-abbb-3535587c1a61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shield System |
| Version Model Number | TPL0001 |
| Company DUNS | 600618211 |
| Company Name | RADIACTION LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +972765394849 |
| info@radiactionmedical.com | |
| Phone | +972765394849 |
| info@radiactionmedical.com | |
| Phone | +972765394849 |
| info@radiactionmedical.com | |
| Phone | +972765394849 |
| info@radiactionmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290018378045 [Primary] |
| OWB | Interventional Fluoroscopic X-Ray System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-23 |
| Device Publish Date | 2022-05-15 |
| 07290018378168 - Spare Part Distal Unit Assembly Middle 3 | 2023-05-17 |
| 07290018378175 - Spare Part Distal Unit Assembly Middle 2 | 2023-05-17 |
| 07290018378182 - Spare Part Distal Unit Assembly Middle 1 | 2023-05-17 |
| 07290018378199 - Spare Part Distal Unit Assembly Corner 1 | 2023-05-17 |
| 07290018378205 - Spare Part Distal Unit Assembly Corner 2 | 2023-05-17 |
| 07290018378045 - Shield System | 2022-05-23 |
| 07290018378045 - Shield System | 2022-05-23 |